The Research Coordinator, with assistance of the Statistician, will prepare data for the quarterly review by the SMB from data stored on a secure computer. The SMB will act independently to review the data. If there is any safety concern related to one or more of these groups, then the Board may choose to identify the actual treatment groups by access to the randomization codes maintained by the pharmacy. Significant adverse events will be reported to the IRB, SMB and FDA within 24 hours.